1. Field of the Invention
The invention relates to the collection and communication of analyte concentration information, and more particularly, to a system for gathering and communicating such data for analysis and treatment.
2. Description of Related Art
Numerous simple test devices have been developed to test for presence and quantity of analytes in aqueous samples, particularly whole blood. The patent and technical literature of the last thirty years is replete with inventions which utilize a dry chemistry reagent system or electrochemical methods to test for analytes in bodily fluids. These systems have been designed so that they can capture various pieces of data such as time of day, date, calorie intake, exercise time and associated glucose readings.
A large government-sponsored study (the DCCT) demonstrated conclusively that careful control of blood glucose levels can significantly reduce the incidence of serious complications of diabetes such as vision loss and kidney malfunction. Most diabetics must test themselves periodically in order to make appropriate adjustments to their diet or medication. Thus, it is especially important for diabetics to have a simple and accurate means to capture their blood glucose readings and provide them to their health care provider for analysis of long-term control.
The technologies embodied in the products which have been developed to date all have certain limitations from the perspective of the end user and/or the manufacturer. The following review of prior art illustrates some of the many adaptations of the approaches which may be found in the patent literature. Numerous types of data collection systems have been utilized to capture reading from test devices for long-term analysis and therapy modulation. Many of these devices have been developed to interface with a local computer system and or upload the information to a disease management system.
Disease management system and the methods for data capture are taught in numerous patents and other prior art. U.S. Pat. No. 5,307,263 to Brown teaches a method which uses various monitors and a data management unit, a hand held unit and a modem to communicate with a clearing house and or user's computer.
U.S. Pat. No. 5,025,374 to Roizen et al. teaches a method of making and using an interactive medical test selector for use by a patient. It includes a memory device for storing the patient responses.
U.S. Pat. No. 4,731,726 to Allen III et al. teaches a method of monitoring a patient using a measuring device linked to a monitoring apparatus capable of receiving and storing data and using this information to generate insulin dosage recommendations.
U.S. Pat. No. 4,546,436 to Schneider et al. teaches the use of a device for continuous recording of physiological data. The system includes a data mapping and compression technique which permits long-term data acquisition.
U.S. Pat. No. 4,531,527 to Reinholdr et al. teaches a cardiac monitoring system which interfaces with an EKG and an office unit which can process the collected data.
U.S. Pat. No. 4,803,625 to Fu et al. describes a personal health monitor which includes sensors and is coupled to a central unit via modems and a computer which is programmed to prompt a patient to take prescribed medication at specific times.
U.S. Pat. No. 5,007,429 to Treatch et al. describes a user interface for direct programming of operating parameters for patient testing of blood pressure and downloading the data to an office control unit.
U.S. Pat. No. 5,019,974 to Beckers describes a diabetes management system and apparatus for efficient medical control for diabetes comprising a recorder, interface module, and master computer which can develop programs of therapy which can be downloaded to the recorder to remind the patient of pending therapy actions.